WASHINGTON -- The FDA has approved the angiogenesis inhibitor bevacizumab for treatment of advanced cervical cancer in combination with chemotherapy.

WASHINGTON -- The FDA has approved the angiogenesis inhibitor bevacizumab (Avastin) for treatment of advanced cervical cancer in combination with chemotherapy.

The approval stipulates use of bevacizumab with the chemotherapy combination of paclitaxel plus cisplatin or paclitaxel plus topotecan. The FDA action follows the agency's granting of priority review status, designed to expedite approval of therapies that represent a demonstrable improvement over existing therapy.

"Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin," Richard Pazdur, MD, director of hematology and oncology products at the FDA, said in a statement. "It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than 4 months under the FDA's priority review program."

As part of the review process, the FDA reviewed data from a clinical study involving 452 patients with persistent, recurrent, or late-stage cervical cancer. Study participants were randomized to paclitaxel-cisplatin or paclitaxel-topotecan chemotherapy with or without bevacizumab. The bevacizumab group had a median overall survival of 16.8 months compared with 12.9 months for patients who received only chemotherapy.

Outside the U.S., the agent has approval for advanced breast cancer and for recurrent, platinum-resistant ovarian cancer. In 2008, the FDA granted accelerated approval of bevacizumab for metastatic breast cancer. However, a review of data submitted after the approval convinced the FDA that the benefits in advanced breast cancer did not outweigh the risks, and the agency revoked the approval in 2011.

Clinical investigation of bevacizumab continues in ovarian cancer and advanced breast cancer. Other areas of investigation include melanoma, rectal cancer, liver cancer, and neuroblastoma. Additionally, studies are evaluating bevacizumab for expanded indications within the types of cancer for which the drug is already approved.

Adverse effect data from the cervical cancer studies indicated that the drug was associated with fatigue, decreased appetite, hypertension, hyperglycemia, hypomagnesemia, urinary tract infection, headache, and weight loss. Consistent with bevacizumab's profile in other indications, some patients developed gastrointestinal perforations and enterovaginal fistulae.

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